Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03426514|
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: Three-port Laparoscopic Surgery Procedure: Conventional Laparoscopic Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer|
|Actual Study Start Date :||March 25, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2025|
Experimental: Three-port Laparoscopic Surgery
Patients with colorectal cancer undergo three-port laparoscopic surgery.
Procedure: Three-port Laparoscopic Surgery
Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery.
Experimental: Conventional Laparoscopic Surgery
Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）.
Procedure: Conventional Laparoscopic Surgery
Patients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction.
- Early morbidity rate [ Time Frame: 30 days after surgery ]morbidity rate 30 days after surgery
- Operative time [ Time Frame: intraoperative ]Operative time（minutes）
- Intraoperative blood loss [ Time Frame: intraoperative ]Estimated blood loss（milliliters，ml）
- Lymph node detection [ Time Frame: 14 days after surgery ]Lymph nodes harvested（numbers）
- Proximal resection margin [ Time Frame: 14 days after surgery ]Length of proximal margin （centimeters，cm）
- Distal resection margin [ Time Frame: 14 days after surgery ]Length of distal margin （centimeters，cm）
- Length of stay [ Time Frame: 1-14 days after surgery ]Duration of hospital stay（days after surgery）
- Postoperative recovery course [ Time Frame: 1-14 days after surgery ]Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
- Pain score [ Time Frame: 1-3 days after surgery ]Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge
- 3-year disease free survival rate [ Time Frame: 36 months after surgery ]3-year disease free survival rate
- 5-year overall survival rate [ Time Frame: 60 months after surgery ]5-year overall survival rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426514
|Contact: Ren Zhao, MDfirstname.lastname@example.org|
|Shanghai, Shanghai, China, 200025|
|Contact: Tao Zhang, MD +86-13918805942 email@example.com|
|Study Chair:||Tao Zhang, MD||Ruijin Hospital|